Agilvax?s AX09 is an Immunotherapy for Triple-Negative Breast Cancer: Agilvax is developing cancer immunotherapies and vaccines with its proprietary virus-like-particle (VLP) platform technology. Agilvax?s lead product, AX09, is an immunotherapy for triple-negative breast cancer (TNBC) targeting cancer stem cells (CSC) that is designed for use in combination with existing and emerging therapies. TNBC is extremely aggressive with high rates of recurrence and overall poor outcomes as compared to other forms of breast cancer. The average 5-year survival rate for metastatic patients with TNBC is only 26.1%. TNBC is more likely to occur in women under the age of 40, and the rate of incidence is higher in African-American and Hispanic populations as compared to Caucasian populations. It is estimated that 30,000 women will be diagnosed with TNBC in 2017. AX09 Targets Breast Cancer Stem Cells to Prevent Relapse and Metastasis: With no CSC targeted therapies currently available, there is a critical need for the development of therapeutics for patients impacted by TNBC. AX09 is composed of a VLP that displays a specific portion of a protein, xCT, that is overexpressed in breast cancer stem cells (BCSC) and contributes to chemotherapeutic drug resistance and metastasis. AX09 is favorably positioned in the emerging market of various treatment approaches targeting TNBC, which will increasingly segment the patient population by novel biomarkers and molecular targets. Due to their resistance to radiation and chemotherapies, BCSC represent a reservoir for the relapse, metastatic evolution and progression after initial treatment. AX09 produces an oligoclonal antibody response against the BCSC target, xCT, that will eliminate BCSC as a source of recurrence. Agilvax?s Aims for the Fast-Track SBIR Include Preclinical Work, cGMP Manufacturing and a Toxicology Study: Agilvax?s goals for this grant are to complete its preclinical work, including upstream and downstream process development of AX09 based on processes the company successfully used in developing another VLP-based product. As part of its first goal, Agilvax will strengthen AX09 efficacy by determining the optimal dosage regimen, confirming efficacy in a second tumor model, and assess the combination of AX09 with other chemotherapeutic agents in planning for the Phase I trial design. Agilvax will proceed with cGMP production and validation of research and master cell banks in order to complete cGMP manufacturing and release testing of AX09 drug substance and drug product. Upon the recommendation of Agilvax?s Key Opinion Leaders in breast cancer, a single nonclinical toxicology study using New Zealand white rabbits is planned.